FDA Dietary Supplement Label Regulations

Quality Smart Solutions ensures your labels meet DSHEA and 21 CFR codes of federal regulations. We review your labels, advise on structure-function claims, prepare a substantiation dossier (if required), and file a premarket notification with the FDA. We guide your products to market and help you stay compliant with the FDA Dietary Supplement Regulations.

Overview of Dietary Supplements

Dietary supplements are health and wellness products that contain dietary ingredients, including minerals, vitamins, herbs, amino acids, botanicals, and other categories of ingredients that can be used to supplement diets. The forms of dietary supplements include but are not limited to tablets, powders, capsules, gummies, and liquids. The supplements are used to improve health, used for the prevention of ailments, and for the maintenance of overall wellness. 

Based on the CRN Consumer Survey on Dietary Supplements conducted in 2019, 77% of Americans consume dietary supplements. The majority of both are males and females, aged 18+ years. Among the age groups, adults between the ages of 35 – 54 years old share 18% consumption, the highest usage of dietary supplements. Consequently, the nutritional supplement industry is witnessing massive growth, primarily in vitamins and protein supplements.

FDA Dietary Supplement Requirements

The FDA governs dietary supplements in the USA. FTC governs the marketing and advertisement of dietary supplements.  Failure to comply with the dietary supplement regulations can result in an FDA warning letter, FTC fines, stop sale, recall, and potential litigation. If you export dietary supplements to the United States it may result in entry refusal and the U.S. Customs and Border Protection Agency detaining your goods. As a manufacturer, importer, or distributor of dietary supplements and dietary ingredients, you’re solely responsible for assessing the safety and labeling of your products. You must ensure products adhere to all the requirements of FDA and DSHEA regulations. Here is a list of requirements to keep in mind for your dietary supplement.

FDA Dietary Supplements
Labeling Requirements

You must follow the labeling requirements, such as nutrition labeling, ingredient labeling, and nutrient content, health claims, dietary supplement packaging regulations, etc.

Supplement Facts Panel

Having a ‘Supplement Facts Panel’ is mandatory for every dietary supplement to be marketed in the USA. The panel must have all information required by FDA.

Notification to the FDA

According to the Federal Food, Drug, and Cosmetic Act, the FDA must be notified within 30 days of your dietary supplement first being marketed in the USA.

Health Claims

The FDA and FTC require health claims about the safety of your dietary supplements that must be supported with reliable scientific evidence.

Types of Dietary Supplement Labels We Have Reviewed

We have reviewed a wide range of Dietary Supplement Product Labels, including but not limited to the following.

Sports Nutrition
Multi Vitamins
Traditional Medicine

End to End Solutions for Dietary Supplements in USA

Our team consists of professionals who have extensive experience with dietary supplement label reviews, preparation of health claim substantiation dossiers, supplement facts panel creation and filing 30 day dietary supplement notifications with the FDA

Dietary Supplement Label Review

Our US regulatory specialists will review your label, Supplement Facts Panel (SFP), Structure-function claims, and give suggestions to meet labeling requirements and ensure SFP is in the correct format

Supplement Facts Panel Creation

Our officers will assist you in creating Supplement Facts Panel with adequate attention to the box, font, thickness, etc., and ensure it strictly adheres to the required format and remain print-ready.

Health Claims Substantiation Dossier

We will empower you to prepare dossiers for supporting the efficacy and safety of your dietary ingredients according to the standards of evidence as described in the Federal Act.

Structure-Function Claims pre-market Notification

Do not worry about structure-function claim notification as our specialists will assist you in preparing the structure-function claim notification and submitting it through mail or electronically.

Dietary Supplement Facility Registration and Renewal

Our US Regulatory experts will help you register or renew your food or dietary supplement facility with FDA. We make the entire registration and renewal process simple and cost-effective

U.S. Agent Service for Dietary Supplement Foreign Facilities

We cater to all criteria required to serve as a US agent. With expert knowledge and extensive experience, we can answer every question the FDA may have in case of an emergency.

FSVP Import Agent for Dietary Supplements

As per FSMA regulations a qualified individual must who is a US representative who ensures the manufacturer follows and practices cGMP. A comprehensive FSVP plan is in place to ensure import requirements are met.

Prior Notice FDA Clearance

If you are shipping dietary supplements into the United States a Prior Notice must be filed before arrival. An FDA confirmation with a bar code must accompany most dietary supplements at the port of entry.

New Dietary Ingredient Notification (NDIN)

We determine if your ingredient is a New Dietary Ingredient, prepare a full dossier for a New Dietary Ingredient Notification, request for FDA pre-submission meeting, and address any questions asked by the FDA.

Some of our Clients We Have Helped Ensure FDA Compliance

Proven Expertise. Companies that have put their trust in us to become FDA-compliant.

Shams W.Pawel Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Donal Gauvreau Sapro

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!

Frequently Asked Questions - FDA Dietary Supplement Regulation

Notifications are required for any new ingredient being formulated into a Supplement or to register any structure-function health claims to be made for your product. It is important that all claims being made, and all ingredients, are verified for compliance.
For a new ingredient, the notification to FDA should be submitted roughly 75 days prior to market introduction. For a structure-function claim notification, it must be filed within 30 days of marketing of the dietary supplement in the USA. During that time, the FDA may issue additional questions or requirements regarding your ingredient or claim. Our specialists are ready to help with your notifications or any related questions. Please contact our team!

FDA regulations require that certain information appears on dietary supplement labels. Information that must be on a dietary supplement label includes:

  • a descriptive name of the product stating that it is a “supplement;”
  • the name and place of business of the manufacturer, packer, or distributor.
  • a complete list of ingredients.
  • the net contents of the product.
  • must have nutrition labelling in the form of a “Supplement Facts” panel. This label must identify each dietary ingredient contained in the product.

For assistance with Dietary Supplement labelling, please reach out to our friendly staff.

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